Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness

China Medical University

Status and phase: Unknown; Phase 2

Conditions: Acute Mountain Sickness (AMS)

Treatments: Drug: Chinese Medicine; Drug: Acetalozamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01682551

NRICM-10101

Details and patient eligibility

About

This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).

Full description

This study is a randomized, double blind, placebo-controlled clinical trial. It aims to demonstrate that (1) Chinese medicine prescription "Wu Zhu Yu Tang" can prevent Acute Mountain Sickness(AMS) (2) "Wu Zhu Yu Tang" can prevent AMS especially for Yang-Xu body constitution.

We will randomize 240 unacclimatized healthy adults. They will be randomized after stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects will fill the "Body Constitution Questionnaire BCQ" in order to evaluate their body constitution. Before, during and after the two days hike we will measure their blood pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the Lake Louise Clinical Assessment score and Lake Louise Functional Score.

Enrollment: 240 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults

Exclusion criteria

• Chronic disease: cardiovascular disease, psychological disease, anemia, migraine.
• long-term use of the following materials: Chinese herbs, steroid, antibiotics.
• altitude acclimation: have been to mountain over 2000m in the past 1 month.
• Pregnancy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Chinese Medicine

Experimental group

Description:

The participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day.

Treatment:

Drug: Chinese Medicine

Acetazolamide

Placebo Comparator group

Description:

If the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang".

Treatment:

Drug: Acetalozamide

Drug: Chinese Medicine